Even though the new way is uncertain, it's not mean that the existing is safe.
Even though the new way is uncertain, it's not mean that the existing is safe.
  • Accepted 2023.04.18 13:57
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Jay Ingram, Dellphic HSE Solutions, EMEA operations Director
Jay Ingram, Dellphic HSE Solutions, EMEA operations Director
Jay Ingram, Dellphic HSE Solutions, EMEA operations Director

Q. Please introduce yourself.

My name is Jay Ingram, I am the Director for EMEA operations at Delphic HSE Solutions Ltd.; this means I have responsibility and oversight over the deliverable work we conduct in the fields of Regulatory Compliance and Toxicological Safety. I have nearly 15 years of experience in conducting toxicological risk assessments on consumer products, to global markets, with an emphasis on cosmetic products. I have also spent the majority of my career focussing on the intersection of toxicological safety and regulatory compliance. I spent a large portion of my early career working for Unilever’s Safety and Environmental Assurance Centre, where I began to learn about how New Approach Methodologies (NAMs) could be applied to the safety assessment of consumer goods. In addition to my role at Delphic HSE I am a contributing member of the Animal Free Safety Assessment collaboration (AFSA) lead by Humane Society International. I am currently writing the educational module focussing on the Global Regulatory Landscape of cosmetic animal test ban legislation. In my spare time, I am also leading the techcnial aspects of how Delphic HSE will further enhance our services within our brand new, state-of-the-art software, APOLLO.

Q. Could you explain about ‘Delphic HSE’?

Delphic HSE Solutions Ltd. is a multinational consultancy that provides specialist product safety and regulatory compliance services to the global consumer and industrial chemicals markets. Our experts help organisations of all sizes meet the complex regulatory needs of their products and consumers. Our primary market is in cosmetic products where we provide a range of service support:

• Toxicological risk assessments of ingredients and formulations

• Review of product labelling and claims

• Guidance to navigate and achieve regulatory compliance in global markets

• Product registration to meet national requirements

• Regulation monitoring to ensure post-market product compliance

• Responsible Person (EU) services and other mandated legal representation of products

• Training for regulatory compliance and responsibilities of manufacturers

• Expert Witness and professional consultation

We have offices in the UK, Netherlands, Hong Kong, and Australia with ambitions to expand our global footprint further. The company started trading 15 years ago and has grown from a 1-person operation to a company of ~60 employees with nearly 30 toxicological risk assessors and 14 regulatory specialists. In summary, our role is to ensure product safety and compliance. In doing so, we protect the consumer, and we protect our clients.

Q. In ACAAE, you presented ‘Global Cosmetics Regulatory Landscape’. What’s the main point of the present?

The purpose of this presentation was to provide an overview of the historical context and current picture of the regulatory landscape as it pertains to the testing of animals to prove safety of cosmetic products. The presentation also explores the complications that have arisen in the implementation of animal test ban regulations and provides opportunities and solutions to overcome these complications.

Q. I’m curious about the recent trends of regulation of the Cosmetics Animal Replacement Test Act. 

Animal test ban legislation is gaining momentum with an increasing number of states debating or passing legislation in this area. Currently there are 42 countries/regions that have implemented legislation fully or partially prohibiting the testing of cosmetic products and ingredients on animals including: European Union, UK, South Korea, India, Mexico, Turkey, Israel, Australia, New Zealand

Certain countries have state-level legislation (Brazil and USA); however, these countries have no federal prohibition on testing cosmetic products or ingredients on animals. Countries and regions that have legislation currently in development include Canada, South Africa, Chile, and the ASEAN region. Lastly, we have also seen some relaxation in the regulatory framework of China. The Cosmetics Supervision and Administration Regulation (CSAR) (2021) has relaxed the previous requirement that any cosmetic product marketed in China required animal testing prior to market release (NB: this does not apply to special cosmetic products, new cosmetic products, or products intended for use by children/infants).

In South Korea, there has recently been an act introduced to the National Assembly known as the Act on the Vitalization of Development, Dissemination, and Use of Alternatives to Animal Testing Methods (VAAM Act). It is hoped that this act will help to pass the Act on the Promotion of Development, Dissemination, and Use of Alternatives to Animal Testing Methods (PAAM Act). This act aims to increase the sharing of research information in the field of New Approach Methodologies by cross-ministerial authorities, which will accelerate the acceptance of animal-free toxicological methods.

Globally we are seeing a cosmetic consumer base who is more aware of animal testing; as a result, there is an increased expectation that cosmetic products should not be tested on animals. We have seen in virtually all regions (even those with animal test ban legislation) that regulators and authorities have not kept pace with these expectations. Indeed, there is significant debate over the demands for animal testing by EU authorities, despite the EU Cosmetics Regulation that prohibits the testing of cosmetic products and ingredients on animals.

Q. What’ the technical trends related to the animal replacement test method for cosmetics?

There are far too many to provide an exhaustive list here. Recently there has been advancement in ocular toxicity testing as the Defined Approaches for Serious Eye Damage And Eye Irritation have recently been validated by the OECD (OECD TG 467), which sits alongside the Defined Approaches on Skin Sensitisation (OECD TG 497). A large amount of work is being conducted on understanding actual, internal dose of chemicals via Physiologically Based Kinetic (PBK) modelling. Additionally, refinement of in vitro assays including “organs on a chip” are showing promising results. The ongoing integration of in silico and mathematical modelling are leveraging existing datasets to enable better decision-making. The best place to discover the recent trends is by engaging with the Animal Free Safety Assessment collaboration (https://www.afsacollaboration.org/cosmetics/). AFSA is putting together a 9 module educational programme that will go into detail on all of the technical advancements being made in New Approach Methodologies (NAMs).

Q. What’s the level of Korea’s R&D of the animal replacement test method and What should be supplemented and focused?

Korea is a country that has restricted the use of animal testing on cosmetic product and ingredients with the Cosmetics Act coming into force in 2018. This represents a good first step in the replacement of animal tests; however, there is still more to be done. The restriction relating to non-animal methods only applies to endpoints for which alternative methods have been approved by the Ministry of Food and Drug Safety (MFDS). These alternative methods only relate to non-complex endpoints (e.g. skin/eye irritation, genetic toxicity) and skin sensitization. This means animal tests may still be conducted to cover repeated dose toxicity and/or developmental and reproductive toxicity. This contrasts with the EU Cosmetics Regulation (EC 1223/2009), which prohibits any animal testing to be conducted on cosmetic products or ingredients, whilst still requiring a safety assessment to be produced.

Korea’s R&D should be focusing on refining and applying New Approach Methodologies (NAMs) that enable human-relevant safety assessments to be conducted. If the benefits of these NAMs can be presented to the MFDS in a compelling manner, the palette of alternative methods available under the Cosmetics Act will grow, thereby improving the quality of safety assessments for cosmetics available on the Korean market. Much progress has been made, now Korea faces an excellent opportunity to push the boundaries and set a new trend in regulatory toxicology.

Q. What do you want to emphasize in this presentation? And Why?

I really want to emphasize the future opportunities and solutions that are available to us in the field of NAMs and safety assessment in the absence of animals. NAMs give us an opportunity to conduct higher quality safety assessments that start from exposure-led, human-relevant principles. In order to realise the benefits of applying NAMs to cosmetic safety assessments we must address the following three areas:

- Understanding of Uncertainty

Uncertainty is a theme that is part of any safety assessment. There is a high level of uncertainty in NAMs; however, this is only due to their relative novelty. Traditional, animal-based toxicological models are associated with a considerable amount of uncertainty. We have become comfortable with the uncertainty that is inherent in these animal-models through many years of use; the level of uncertainty is constant, our level of comfort is changeable. Therefore, when it comes to NAMs we need to identify the sources and level of uncertainty, then begin to increase our comfort in understanding the information that is being provided from the methods. NAMs are increasingly being seen to provide more human-relevant and conservative points of departure than traditional, animal-based methods, as was explained by Friedman et al. (2020).

- Building confidence through engagement & education

One of the best ways in increasing our level of comfort is by building confidence in NAMs. This can only be done by intentional, open-minded engagement and education. The Animal Free Safety Assessment Collaboration (AFSA) lead by Humane Society International is working to provide a suite of educational modules relating to the development and application of NAMs. The goal of this collaboration is to bring together and educate industry, academia, regulators, and NGOs to harmonise the levels of understanding and build confidence in the application of NAMs in cosmetic safety assessment. Engagement is critical in ensuring the valuable data generated using NAMs is able to be applied in real-world scenarios; in order for this to take place all four parties must be prepared to be more open and commit to dialogue as we progress along this journey.

- Constructing Holistic Legislative Frameworks.

Cosmetic products do not exist in isolation. All cosmetic products are made of chemicals; therefore, cosmetic products and their ingredients are impacted either directly or indirectly by other pieces of legislation (e.g. K-REACh, and UN GHS). These other pieces of legislation may undermine the goals of animal test ban legislation relating to cosmetics, by requiring the provision of toxicological information via specific, inflexible testing guidelines. The way these regulations are framed and interpreted frequently results in a significant increase in the use of animals in toxicological studies, without enabling these information requirements to be fulfilled using NAMs. NAMs may use a variety of different assays to arrive at a human-relevant safety conclusion; often, regulations are not flexible enough to be able to receive this data.

Additionally, banning the use of animal tests does not equal acceptance of non-animal methods. As we build our collective confidence in leveraging NAMs, I hope policy-makers and competent authorities will be able to build and interpret legislative frameworks that are exposure-led, human relevant, and hypothesis driven. These frameworks must be flexible and holistic to avoid loopholes that we often see in animal test ban regulation whereby animal testing will be permitted to satisfy the requirements of other regulations. The US Toxic Substances Control Act 2016 update is a good example of incorporating and promoting NAMs into policy that will be impact a number of industries, not only cosmetics.

Q. As far as I know, the Delphic HSE provides the Global Regulatory Information Program (GRIP). Please explain about this service. What are the advantages? What’s the difference between regulatory services in other companies and countries?

GRIP is a subscription-based, flexible service that provides our clients with the most relevant and current information on safety regulations so that they can make informed decisions on product development and distribution and the effect on the lifecycle of their products. Using our own unique database, global network, and key collaborations, we continuously monitor governing-industry communications for changes, or proposed changes, to regulations affecting finished products currently in-market or due to enter the market. Delphic GRIP also provides updates on changes to chemical regulations on restricted, novel or banned substances. Subscribers to GRIP receive monthly email notifications highlighting all global regulatory changes (including those that are pending). The email will provide headline information relating to each regulatory change and include a link to the fully transcribed details of each piece of regulatory news.

Subscribers also have access to the fully transcribed data via a web-based, password protected portal. Data transcription is conducted by Delphic HSE technical experts, including full Quality Assurance prior to release. For transparency, the data that is made available to subscribers, is the same data that is used to support the 45,000+ services that Delphic HSE deliver on behalf of over 450 clients, each year.

This access also provides a repository of all current and previous regulatory changes that can be searched and filtered to find the desired results. This search includes date, region, and ingredient filters.

One of the key differentiating benefits that GRIP offers is that all Subscribers will have access to a GRIP Clinic, whereby the Subscriber can arrange a time to speak directly with a Delphic HSE regulatory expert and discuss any of the changes and their impact as well as any specific areas of concern. Many regulatory information subscription services simply allow subscribers to view summaries of regulatory update information; Delphic HSE offers this personalised one-to-one collaboration to help answer the questions that really matter to our clients.

Q. Please tell us what you would like to emphasize or add through this interview.

We all have a responsibility to be open-minded and engaged in advancing the application of NAMs, regardless of whether we work in government, industry, academia, or NGOs. We must learn to better understand each other’s motivations and concerns. The only way this can be done is through meaningful dialogue and education; AFSA provides an incredible platform for both education and dialogue. We share a common goal of ensuring the safety of humans and environment as they interact with consumer products and the ingredients contained within these. The best way of doing this is to ensure pragmatic decision-making is at the heart of all we do. Many people feel that the application of NAMs is too risky and the technology is not ready; however, we must be prepared to recognise that our discomfort with new uncertainty does not mean the uncertainty of traditional methods is any safer. The application of NAMs will require trust, which is difficult to gain but easy to lose; this is why dialogue is critical to ensuring we can move to a place where we are using the best available science and technology to ensure and improve the safety of humans and the environment.

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